510(k) · Cleared
ClearedOrbital Tissue Expander (Ote)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovia, LLC · NFM Expander, Tissue, Orbital
Cleared on Aug 8, 2006 as substantially equivalent to K010852 (Iop, Inc., 2001) after a 200-day review. Its family tree reaches back 1 generation to 2001. 2 later devices descend from it.
- Decided
- Aug 8, 2006
- Review
- 200 days
- Class
- Class II
- Product code
- NFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010852 (2001). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK010852 Osmed Tissue ExpanderIop, Inc. · 2001
- This deviceK060151 Orbital Tissue Expander (Ote)Innovia, LLC · 2006
- Descendant · cites it directly · 1 of its ownK070130 Orbital Reconstructive ImplantBecker & Associates Consulting, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK083342 Orbital Reconstructive Implant IIEvera Medical, Inc. · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010852 | Osmed Tissue Expander | Iop, Inc. | 2001 | — |
| 0 (this device) | K060151 | Orbital Tissue Expander (Ote) | Innovia, LLC | 2006 | — |
| +1 | K070130 | Orbital Reconstructive Implant | Becker & Associates Consulting, Inc. | 2007 | — |
| +2 | K083342 | Orbital Reconstructive Implant II | Evera Medical, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NFM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K010852 | Osmed Tissue ExpanderSummary page 1…llc.com Date Prepared: January 18, 2006 Name of Device: Orbital Tissue Expander (OTE) Equivalent Device: Osmed Hydrogel Tissue Expander from IOP Inc. (K010852) Intended Use: The OTE would be used in the case of congenital anophthalmia, congenital microphtha… | 2001 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070130 | Orbital Reconstructive Implant | 2007 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K070130 (Becker & Associates Consulting, Inc., 2007) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NFM devicesNFM Expander, Tissue, Orbital: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NFM
FDA has decided no NFM device since 2007.
Median 510(k) review, days · NFM
Too few NFM 510(k)s in any year since 2007 to give a median.
Recalls per year · NFM
No recall names NFM since 2007.
Adverse event reports per year · NFM
No MAUDE report names NFM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The OTE would be used in the case of congenital anophthalmia, congenital microphthalmia or acquired anophthalmia from, e.g., childhood ocular tumors or trauma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060151 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060151: Orbital Tissue Expander (Ote).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060151
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026